Drugs

Merck Refiling Gedapixant NDA Next Year

Merck says it will file a response in the first half of 2023 to an FDA complete response letter it received in January on an NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refractory chronic cough or unexplained chronic cough in adults. The company says it is performing additional analyses, which will be submitted in its response. The letter reportedly requested additional information related to the cough counting system that was used to assess efficacy, and it did not cite any issues related to gefapixant’s safety.

Merck says that a refractory chronic cough is one that persists despite appropriate treatment of underlying conditions and an unexplained chronic cough is one where the underlying cause cannot be identified despite a thorough evaluation.

P2X3 receptors are one of the receptor types found on sensory nerve fibers, predominantly C fibers, in the airway lining, according to the company. “Chemical stimuli, including adenosine triphosphate (ATP), can be released from airway lining cells due to airway inflammation, irritation and mechanical stress/injury,” it says. “The inhibition of binding of extracellular ATP to P2X3 receptors is thought to reduce sensory nerve activation and, subsequently, cough.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome